Actos, a drug used to treat Type 2 diabetes, may be associated with an increased risk of bladder cancer when the medication is used over a long period of time. In 2011, new warnings were added to the Actos label in the U.S. detailing the potential for this serious and potentially deadly complication. That same year, an Actos recall was issued in France, while German regulators suspended sales of the drug. In the years since, thousands of people in the U.S. have filed Actos lawsuits accusing Takeda Pharmaceutical of failing to warn doctors and patients about the medication’s association with bladder cancer.
You may be entitled to compensation if you or a loved one were diagnosed with bladder cancer while taking Actos. As both an attorney and practicing physician, Dr. François Blaudeau possesses a unique understanding of the medical and legal questions at issue in Actos bladder cancer lawsuits. To learn more about your legal rights, please call Dr. Blaudeau as soon as possible for a free, no-obligation case review.
Actos and Bladder Cancer
Actos (pioglitazone) was approved by the U.S. Food & Drug Administration (FDA) in July 1999 as a treatment for type 2 diabetes. In addition to Actos, pioglitazone is also the active ingredient in ActosPlus Met, ActosPlus Met XR and Duetact.
Prior to its approval, clinical trials indicated that rats exposed to Actos were prone to developing tumors. But the drug’s labeling maintained that the relationship between the tumors in rats and possible tumors in humans was “unclear.” By 2005, two studies conducted by Takeda revealed that people taking Actos were more likely to develop bladder cancer than those taking another drug. The following year, the Actos label was modified to include information from a two-year study that showed bladder tumors in rats given high doses.
On June 15, 2011, the FDA announced that the “Warnings and Precautions” section of the Actos label would be updated to include interim findings from a 10-year study indicating that people who used the drug for a year or more were 40% more likely to develop bladder cancer. The agency advised that Actos should not be used in patients with bladder cancer, and should be used with caution in those with a history of the disease. All other Actos patients should be carefully monitored for signs and symptoms of bladder cancer, including:
- Blood in urine
- Back or lower abdominal pain
- Urgent need to urinate
- Pain during urination
That same month, regulators in France and Germany decided to suspend sales of Actos due to its connection with bladder cancer. Takeda would eventually issue an Actos recall in France.
Following the FDA’s public communication regarding Actos and bladder cancer, thousands of people filed product liability lawsuits against Takeda. The majority of those claims are pending in a multidistrict litigation underway in U.S. District Court, Western District of Louisiana, where nearly 4,000 Actos lawsuits had been filed by the end of 2014. (In re: Actos Product Liability Litigation, MDL No. 2299)
In April 2014, the federal litigation’s first bellwether trial concluded with a jury awarding $9 billion in compensatory and punitive damages to a man who had developed bladder cancer after using Actos for five years. During the trial, attorneys for the plaintiff presented evidence indicating Takeda was warned about the drug’s association with bladder cancer a full seven years before it notified the public. The jury hearing the case found that Takeda failed to provide adequate warnings about Actos’ potential to cause bladder cancer, and that company officials acted with “wanton and reckless disregard” in their handling of the drug.
Legal Help for Victims of Actos Bladder Cancer
Throughout his career, Dr. Blaudeau has worked hard to develop a strong reputation in healthcare litigation. His first-hand knowledge of medicine has made Southern Med Law an aggressive and effective advocate for those who were harmed due to dangerous and defective drugs. If you believe you or a loved one developed bladder cancer due to long-term Actos treatment, please contact the Firm today to learn more about your legal rights. You can arrange for a free, no obligation Actos bladder cancer lawsuit review by filling out our online form, or by calling the office directly at 205-547-5525.